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Completed

NCT Number: NCT03778827

A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism

The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spectrum disorder (ASD).

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Key information

Conditions

Autism Spectrum Disorder Autism Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

2 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based preschool environment to treat social communication deficits in children with autism spectrum disorder (ASD). The study will compare Pivotal Response Treatment (PRT) to a delayed treatment group (DTG). PRT is a naturalistic behavioral intervention based on the principles of applied behavior analysis which has shown to be effective in treating the core deficits in children with ASD. The study will compare the combination of parent training with intensive center-based PRT (PRT-C) to a DTG and will include 44 children ages 2 to 3.11 years with ASD and social communication deficits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Autism Spectrum Disorder (ASD) based on clinical interview and Diagnostic and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) or Childhood Autism Rating Scale (CARS-2); Diagnostic and Statistical Manual, 5th edition (DSM-5), and expert clinical opinion
  • Boys and girls between 2 years and 3 years and 11 months
  • Ability to participate in the testing procedures to the extent that valid standard scores can be obtained
  • Stable treatment (e.g., applied behavior analysis (ABA), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
  • Developmentally delayed with Mullen Scales of Early Learning (MSEL) or Developmental Profile (DP-4) composite score below 85 (1 Standard Deviation below the mean)
  • Availability of at least one English-speaking parent who can consistently participate in parent training and research measures.

Exclusion criteria

  • Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.)
  • Presence of active medical problem (e.g., unstable seizure disorder or heart disease)
  • Child primary language other than English
  • Previous adequate trial of Pivotal Response Treatment
  • More than 15 hours per week of in-home applied behavior analysis (ABA).

Treatment and study plan

Intensive Center-Based Pivotal Response Treatment (PRT-C)

Behavioral

Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of weekly individual parent training sessions and center-based therapy for a total of 13 weekly treatment hours.

Primary outcomes

  1. Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks

    Time frame: Baseline and Week 12

  2. Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks

    Time frame: Baseline and Week 12

  3. Mean change from baseline on the frequency if the child's functional utterances on the structured lab observation at 12 Weeks

    Time frame: Baseline and Week 12

Secondary outcomes

  1. Mean change from baseline on the Vineland Adaptive Behavior Scales 3rd Edition Socialization subscale at 12 Weeks

    Time frame: Baseline and Week 12

  2. Mean change from baseline on the MacArthur-Bates Communication Development Inventory at 12 Weeks

    Time frame: Baseline and Week 12

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • John & Marcia Goldman Foundation

Registry information

Official study title

A Center Based Randomized Controlled Trial of Pivotal Response Treatment for Preschoolers With Autism

Acronym: PRT-C

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2018
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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